Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia

Hyperglycemia Clinical Trial

Official title:

Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01184014
• Other study ID #: 04000-10-C
• Status: Completed
• Phase: Phase 4
• Start date: August 2010
• Est. completion date: August 2012

Study information

• Verified date: November 2013
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the best insulin regimen for hospitalized patients who receive high doses of steroids who have high blood glucose.

Description:

The overall study objective of this research is to establish the efficacy and assure the safety of achieving glycemic control in hospitalized patients who receive greater than physiologic doses of steroids. This study will compare 2 methods of achieving glycemic control in hospitalized patients who develop steroid-induced hyperglycemia (blood glucose (BG) >180 mg/dL): 1) a study-specific steroid NPH dosing algorithm plus standard recommended care (Experimental group) vs. 2) the standard recommended care (Methodist Hospital Complete Insulin Orders (Control group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women aged =18 years who receive steroids in doses greater than physiologic replacement levels of = 10 mg Prednisone or its equivalent of dexamethasone or methylprednisolone.

• Have signed the consent form for the study

• Have a BG > 180 mg/dL any time during the first 24 hour of steroid administration that is above physiological replacement ( = 10 mg Prednisone or equivalent)

• Are scheduled to be in hospital = 2 days.

Exclusion Criteria:

• Unable to read or understand English

• History of psychiatric disability affecting informed consent or compliance with drug intake

• Type 1 diabetes

• Acute or chronic renal failure (creatinine clearance < 30 mL/min estimated by method of Cockcroft and Gault)

• Patients in Hospice Care

• Age <18 years

• Previously enrolled in this study.

• Not appropriate for the steroid protocol in judgment of the principal investigator and/or attending physician.

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Drug:
• NPH insulin plus Complete Insulin Orders
NPH dosed per study-specific algorithm which incorporates total daily dosage of steroid to determine NPH dose. Complete insulin orders include background, meal-time and correction factor.
• Complete Insulin Orders
3-part insulin which includes background, meal-time and correction factor

Locations

Country	Name	City	State
United States	Park Nicollet Health Services Methodist Hospital	Saint Louis Park	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	International Diabetes Center at Park Nicollet, Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (3)

Clore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR. Review. — View Citation

Derendorf H, Hochhaus G, Möllmann H, Barth J, Krieg M, Tunn S, Möllmann C. Receptor-based pharmacokinetic-pharmacodynamic analysis of corticosteroids. J Clin Pharmacol. 1993 Feb;33(2):115-23. — View Citation

Donihi AC, Raval D, Saul M, Korytkowski MT, DeVita MA. Prevalence and predictors of corticosteroid-related hyperglycemia in hospitalized patients. Endocr Pract. 2006 Jul-Aug;12(4):358-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Blood Glucose of All Readings	Starting 3 hours after the initial index blood glucose (BG) >180 measure, across the entire hospital stay or up through 5 days if hospital length of stay (LOS) is > 5 days	starting 3 hours after the initial index BG>180 measure, across the entire hospital stay or up through 5 days if hospital LOS is > 5 days